Table 5.

Tests for the management of COVID-19 patients (IL-6 assays) granted FDA Emergency Use Authorization.

Company Name	Diagnostic Product (EUA Date)	Materials (Required or Suggested)	Analyzing Systems	Assay Technology Measuring Interval
Siemens Healthcare Diagnostics	ADVIA Centaur IL-6 assay (18 December 2020)	ADVIA Centaur Ancillary Probe Wash, Centaur Wash, IL-6 Quality Control	ADVIA Centaur XP, XPT, CP systems	One-step direct chemiluminescent IL-6 immunoassay; 3.0–5500.0 pg/mL
Beckman Coulter	Access IL-6 assay (1 October2020)	Access IL-6 Calibrators, Access Sample Diluent A, Access Substrate, Access 2 UniCel DxC 600i, IL-6 Quality Control	Access 2, Dxl 600, Dxl 800 systems	One-step immunoenzymatic (“sandwich”) IL-6 assay; 2–1500 pg/mL
Roche Diagnostics	Elecsys IL-6 assay (2 June 2020)	IL-6 CalSet, PreciControl Multimarker, Diluent MultiAssay, ISE Cleaning Solution/Elecsys SysClean	Cobas 8800, 6800 systems	Electrochemiluminescence IL-6 immunoassay; 1.5–5000 pg/mL
Specimen Types: human serum or plasma; Storage conditions: 2–8 °C for 28 days; Approved FDA EUA Uses: (i) Measure IL-6 levels in COVID-19 patients; (ii) Identify severe inflammatory response from elevated IL-6; (iii) Determine the risk of intubation with mechanical ventilation